Class 1 Medicines Recall – For immediate action. Recall to GPs, clinic, hospital, community pharmacy and wholesaler level
Ref: EL(11)A/24
21/10/11
Preflucel vaccine
(manufactured by Baxter Healthcare)
PL 0016/0654
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
VNV5L010C |
31/07/2012 |
Single units |
8 September 2011 |
The above batch of Preflucel (seasonal influenza) vaccine is being recalled due to a higher than expected reports of adverse reactions. No Preflucel should be administered to patients.
Suspected adverse reactions should be reported to the MHRA via a yellow card.
These can be downloaded from the MHRA website or obtained from MHRA, Freepost Yellow Card.
See Appendix 1 for frequently asked questions as provided by the MHRA.
For medical information, contact Baxter Healthcare on 01635 206123.
For stock return queries contact your original distributor.
APPENDIX 1
Can you provide more information about the adverse reactions?
The reports of reactions following use of this batch of vaccine have been mainly from other countries and have mostly been mild and short-lived. They are of the types usually associated with influenza vaccines. However, they have been reported more frequently with the implicated batch than with other batches. The cause is not known and is the subject of investigations by the manufacturer and regulatory authorities.
I have egg allergic patients who need vaccination – can I use alternative vaccines?
Yes. Any at risk patient who has an egg allergy should seek medical advice from their GP before receiving a replacement low-egg content product.
Low egg-content flu vaccines are available and can be given safely to those with egg allergy, even severe egg allergy, as long as guidance is followed. Such patients should be referred to specialists for vaccination in hospital using vaccine with an ovalbumin content less than 0.12 μg/ml (i.e. containing less than 0.06μg per 0.5ml dose). A split dose schedule may be required at the discretion of the supervising physician.
Further guidance is available in the influenza chapter of the Department of Health Green Book.
Will there be any shortages caused by the recall?
Adequate amounts of alternative products are available and no supply problems are foreseen.
Are there any concerns about the level of protection for patients who have been vaccinated?
No. There is no suggestion that the level is compromised or any revaccination is needed.
When will further batches of Preflucel be available for use?
This is not currently known. One further batch (VNV5L012C) is held in the supply chain. This has been quarantined pending investigations and no further Preflucel of any batch should be administered at this time.
